Topamax Lawsuit

Topamax lawsuits are about to rise dramatically in light of new studies linking specific birth defects, namely cleft lip and cleft palate, to Topamax use by expectant mothers.

Our lawyers think the Topamax lawsuits are well positioned to eventually lead to an MDL (which has since happened since this was originally written in 2011). Topamax class action lawsuit based on two fundamental claims: Topamax should have never been put on the market, or at very least should have been recalled, and Topamax was prescribed to patients who did not have symptoms Topamax was intended to control.

Topamax Not Have Been Put on the Market/Topamax Recall Should Have Occured

First, Topamax’s manufacturer Ortho-McNeil knew or should have known that Topamax would lead to cleft lip and/or cleft palate deformities in the children of pregnant woman taking Topamax. There is no reason why the studies that have been done which show the association between cleft lip/cleft palate injuries could not have been done before Topamax was commercially available.

One study shows that expecting mothers on Topamax are 21.3 times more likely to give birth to infants with oral birth defects (most notably, cleft lips or cleft palates) compared to the risk in a background population of untreated women. Let’s pretend, without any evidence, that the study exaggerates the risk and it is half what the data indicates. That would mean that the children born to women on Topamax during pregnancy still have 10 times the risk of an oral birth defect. They should have known that moms taking Topamax during pregnancy were putting their unborn children at a ridiculously high risk of developing cleft lip and/or cleft palate.

Worse still is the fact that the injury occurs often before a woman even knows that she is pregnant. So it is not just women that know they are pregnant that are risk, any woman of childbearing age could get unexpectedly pregnant and have a child with a cleft lip/cleft palate.

Pushing Topamax for Patients That Don’t Have Epilepsy

Okay, you might be saying, drugs come with risks. Topamax treats epilepsy, apparently with great success, and maybe there are some women who did not expect to get pregnant who used Topamax for epilepsy. I agree. I don’t think that particular class of cases is going to fare particularly well. (this is the fact pattern J&J will push to the top for an MDL bellwether trial.)

But the reality is that while you can make a lot of money selling a good epilepsy drug and a lot more money making an ever broader appeal. The FDA approved Topamax as an anti-epileptic drug not for any psychiatric use. But Topamax was criminally marketed to expand the reach of sales of Topamax far beyond the limited conditions for which the drug was approved. An assertion like this sounds like plaintiffs’ attorney hype to gin up lawsuits but, unfortunately this is fact, not fiction.

Ortho-McNeil pled guilty and paid $6.14 million in criminal fines for the misbranding of Topamax. Ortho-McNeil also paid an additional $75.37 million to resolve civil allegations (mostly reimbursement for fraudulent Medicare claims). The U.S. government said that Ortho-McNeil promoted Topamax with the oldest trick in pharmaceutical sales: hiring doctors to join sales representatives in promoting Topamax for unapproved uses in unapproved doses for medical indications not covered by those programs. The federal share of the civil settlement is $50,688,483.52, and the state Medicaid share of the civil settlement is $24,681,516.48.

What’s the motivation here? A lot of money has been made selling Topamax. From January 2007 through December 2010, approximately 32.3 million Topamax prescriptions were filled for over 4 million people in the United States. Ortho-McNeil has made a fortune off of Topamax. No matter how the Topamax lawsuits turn out, this fact is not going to change. But maybe Ortho-McNeil/Johnson & Johnson will be required to give some of that money back to children who are going to suffer from the trauma of dealing with these birth injuries, including the surgical costs for the corrective surgery that very young children – infants, actually – have to undergo because their mother was prescribed Topamax while she was pregnant.